Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT04176133
Eligibility Criteria:
Inclusion:
* Men and women of age 65 years and older at the time of enrollment
* Eligible to receive Fluzone High-Dose
* Female subjects must be past menopause and not pregnant
* No history of anaphylactic reaction to gelatin, neomycin, or other vaccine component
* Must not have had the flu vaccine within the past 90 days
* Medically stable with no exacerbations or changes in medication regimen for chronic diseases in the past 3 months and no hospitalizations in the past 6 months
* Must be able to read/write English in order to provide informed consent and comply with study procedures
* Expected to be available for the duration of the study
Exclusion:
* Receipt of any other vaccines within the past 30 days prior to enrollment
* Acute illness within the last 7 days
* History of hypersensitivity to the flu vaccine or its components (including gelatin, formaldehyde, octoxinol, thimerosal, and chicken protein).
* History of Guillain Barré syndrome (GBS)
* History of bleeding disorders
* Medical contraindication to treatment with vaccine as indicated by a history of autoimmune disease, immune deficiency, or hypersensitivity to other vaccines.
* Unstable major cardiovascular, renal, endocrine, immunological or hepatic disorder
* Systolic blood pressure (SBP) \< 110 mmHg or orthostatic hypotension \[\>20 mmHg fall in SBP or \>10 mmHg fall in diastolic blood pressure (DBP) with standing\] at the time of screening.
* Evidence of an ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infections) (within 14 days prior to entolimod administration). Note: Subjects with localized fungal infections of skin or nails are eligible.
* Clinical signs of febrile illness (temperature \>99.5oF)
* Baseline vital signs with ≥Grade 2 abnormalities
* Significant cardiovascular disease (e.g., myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism, venous thromboembolism) within 6 months prior to study drug administration; symptomatic dysrhythmias or unstable dysrhythmias requiring medical therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association Class 3 or 4 congestive heart failure; or uncontrolled Grade ≥3 hypertension (diastolic blood pressure ≥100 mmHg or systolic blood pressure ≥160 mmHg) despite antihypertensive therapy.
o Significant screening ECG abnormalities, including unstable cardiac arrhythmia requiring medication, atrial fibrillation, 2nd-degree atrioventricular (AV) block type II, 3rd degree AV block, or Grade ≥2 bradycardia (within 14 days prior to entolimod administration).
* Inadequate hepatic function (within 14 days prior to entolimod administration):
* Serum alanine aminotransferase (ALT) ≥3 × upper limit of normal (ULN) (Grade ≥1).
* Serum aspartate aminotransferase (AST) ≥3 × ULN (Grade ≥1)
* Serum alkaline phosphatase (ALP) ≥5 × ULN (Grade ≥2)
* Serum bilirubin ≥1.5 × ULN (Grade ≥1)
* Positive antiviral serology:
* Positive hepatitis C virus (HCV) antibody or positive HCV ribonucleic acid (RNA) by quantitative PCR.
* Positive hepatitis B surface antigen (HBsAg) and negative hepatitis B core (HBc) antibody or undetectable hepatitis B (HBV) deoxyribonucleic acid (DNA) by quantitative polymerase chain reaction (PCR) testing.
* Positive human immunodeficiency virus (HIV) antibody.
* Use of medication that might interact with the flu vaccine including (but not limited to) specifically: aminopyrine, phenytoin sodium, theophylline, and warfarin sodium.
* Any ongoing treatment with immunosuppressive or immune-stimulant therapy
* Ongoing use of systemic corticosteroids.
* Blood or blood products given within the three months prior to vaccination and two months after vaccination
* Current and/or expected receipt of chemotherapy, radiation therapy or any other cytotoxic or immunosuppressive therapy \[i.e. more than 10 mg of prednisone given daily or on alternative days for 2 weeks or more in the past 3 months\]
* Receipt of another investigational pharmaceutical product within 60 days of treatment
* Diagnosis of Parkinson's Disease, previous stroke, or significant cognitive impairment (defined as MMSE \<20)
* Other concerns that in the opinion of the PI would preclude a subject from participating in study procedures or from completing the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT04176133
Study Brief:
Protocol Section:
NCT04176133